Current Regulatory and Litigation Developments in the 510(k) Process: Everything You Need to Know and More

Previously Recorded on June 27, 2019

The 510(k) process has been the subject of recent media attention as well as litigation. Many have alleged that “substantial equivalence” is too low a bar for clearance of medical devices and have called for more rigorous investigation on the part of the FDA. In this webinar, seasoned attorneys Beth Rose of Sills Cummis & Gross and Paul Farquharson of Semmes will look at recent litigation involving 510(k) products and processes, what the FDA is doing, if anything, to address perceived shortcomings in the process, and what the medical device industry can expect going forward.

In this webinar, you will learn:

  • How and why the 510(k) process has come under fire lately;
  • How plaintiffs have attempted 510(k) evidence at trial and whether such evidence has been admissible; and
  • Predictions for the future of the 510(k) regulatory pathway.

Beth S. Rose is a Member of Sills Cummis & Gross, where she chairs the Product Liability Practice Group and is a Co-Chair of the Litigation Practice Group. She has tried complex product liability cases to verdict in state and federal courts throughout the country. Ms. Rose has over 25 years of experience successfully defending complex product liability matters for a variety of regulated products including pharmaceuticals, medical devices, consumer products, foods, chemicals and construction/industrial machines. She also has experience defending product liability cases which arise from clinical trials and catastrophic workplace accidents. During her career, Ms. Rose has served as national counsel to several companies, including those in the pharmaceutical, medical device and contract research organization spaces, defending mass tort litigation. She has also served as New Jersey counsel to entities defending complex product liability claims in New Jersey’s Multi-County Litigation system. Since 2008, she has been recognized in the Chambers USA® Guide to America’s Leading Lawyers for Business. Since 2014, she has been named in Benchmark’s Top 250 Women in Litigation, the Definitive Guide to the Leading Female Attorneys in the U.S.® Ms. Rose received her B.A. with honors from Wesleyan University and her J.D. from Georgetown University Law Center.

Paul N. Farquharson is a principal with Semmes, Bowen & Semmes, P.C. and practices out of the firm's Baltimore and Washington offices. Paul leads the Firm’s Special Risk & Complex Litigation Group. He has successfully defended clients in high exposure insurance coverage, toxic tort, and product liability disputes for over 30 years. During that time Paul has served and continues to serve clients in various capacities, including as national and multi-district litigation counsel for product manufacturers and distributors in drug and medical device litigation. Paul also has been heavily involved in several large insurance coverage cases involving environmental clean-up costs, bodily injury, property damage, and product liability claims. Paul is an experienced trial lawyer and has tried cases in multiple jurisdictions and venues, including London-based arbitration proceedings. Paul obtained his B.A. from Washington & Lee University (1984, magna cum laude, Phi Beta Kappa) and his J.D. from the University of Virginia (1987). He has pursued studies in philosophy and English at the University of London, Oxford (U.K.), and Cambridge (U.K.). 

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